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Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications.

Fri, 07/02/2010 - 5:31am
U.S. Food & Drug Administration

[Federal Register: July 2, 2010 (Volume 75, Number 127)]

[Notices]

[Page 38532-38533]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr02jy10-79]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-M-0068, FDA-2010-M-0078, FDA-2010-M-0063, FDA-

2010-M-0135, FDA-2010-M-0158]

Medical Devices; Availability of Safety and Effectiveness

Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of

premarket approval applications (PMAs) that have been approved. This

list is intended to inform the public of the availability of safety and

effectiveness summaries of approved PMAs through the Internet and the

agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety

and effectiveness data to the Division of Dockets Management (HFA-305),

Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Please cite the appropriate docket number as listed in table

1 of this document when submitting a written request. See the

SUPPLEMENTARY INFORMATION section for electronic access to the

summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices

and Radiological Health, Food and Drug Administration, 10903 New

Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993-0002, 301-

796-6570.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 30, 1998 (63 FR 4571), FDA

published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to

discontinue individual publication of PMA approvals and denials in the

Federal Register. Instead, the agency now posts this information on the

Internet on FDA's home page at http://www.fda.gov. FDA believes that

this procedure expedites public notification of these actions because

announcements can be placed on the Internet more quickly than they can

be published in the Federal Register, and FDA believes that the

Internet is accessible to more people than the Federal Register.

In accordance with section 515(d)(4) and (e)(2) of the Federal

Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and

(e)(2)), notification of an order approving, denying, or withdrawing

approval of a PMA will continue to include a notice of opportunity to

request review of the order under section 515(g) of the act. The 30-day

period for requesting reconsideration of an FDA action under Sec.

10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA

begins on the day the notice is placed on the Internet. Section

10.33(b) provides that

Page 38533

FDA may, for good cause, extend this 30-day period. Reconsideration of

a denial or withdrawal of approval of a PMA may be sought only by the

applicant; in these cases, the 30-day period will begin when the

applicant is notified by FDA in writing of its decision.

The regulations provide that FDA publish a quarterly list of

available safety and effectiveness summaries of PMA approvals and

denials that were announced during that quarter. The following is a

list of approved PMAs for which summaries of safety and effectiveness

were placed on the Internet from January 1, 2010, through March 31,

2010. There were no denial actions during this period. The list

provides the manufacturer's name, the product's generic name or the

trade name, and the approval date.

Table 1--List of Safety and Effectiveness Summaries for Approved PMAs

Made Available From January 1, 2010, through March 31, 2010

------------------------------------------------------------------------

PMA No. Docket Approval

No. Applicant Trade Name Date

------------------------------------------------------------------------

P010047 Neomend, Inc. PROGEL PLEURAL AIR LEAK January

FDA-2010-M-0068 SEALANT 14, 2010

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P060040/S005 Thoratec Corp. THORATEC HEARTMATE II January

FDA-2010-M-0078 LEFT VENTRICULAR ASSIST 20, 2010

SYSTEM (LVAS)

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H080002 Medtronic, MEDTRONIC MELODY January

FDA-2010-M-0063 Inc. TRANSCATHETER PULMONARY 25, 2010

VALVE (MODEL PB10) AND

MEDTRONIC ENSEMBLE

TRANSCATHETER VALVE

DELIVERY SYSTEM (NU10)

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P090003 Boston EXPRESS LD LLIAC March 5,

FDA-2010-M-0135 Scientific PREMOUNTED STENT SYSTEM 2010

Corp.

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P090006 Medtronic COMPLETE SE VASCULAR March 17,

FDA-2010-M-0158 Vascular STENT SYSTEM 2010

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II. Electronic Access

Persons with access to the Internet may obtain the documents at

http://www.fda.gov/cdrh/pmapage.html.

Dated: June 28, 2010.

Nancy Stade,

Acting Associate Director for Regulations and Policy, Center for

Devices and Radiological Health.

[FR Doc. 2010-16139 Filed 7-1-10; 8:45 am]

BILLING CODE 4160-01-S

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